复方库拉索芦荟多糖凝胶剂处方工艺研究及其体外释药特性评价

Study on prescription technology of compound Aloe vera L. polysaccharide gel and in vitro release characteristics

目的优化复方库拉索芦荟多糖凝胶剂(CAVPG)的处方工艺,评价其体外释药特性。方法以空白凝胶剂的外观、涂展性、黏度、高温稳定性(55℃水浴放置5 h)、低温稳定性(-20℃放置24 h)为考察指标,初步筛选凝胶剂基质;以不同基质制备的CAVPG凝胶剂中库拉索芦荟多糖(AVP)、纳米银、纳米锌的累积释放率为指标,确定CAVPG凝胶剂基质;以基质用量、甘油用量、搅拌温度为考察因素,采用正交试验优化处方工艺;以AVP、纳米银、纳米锌的累积释放率为指标,采用转篮法测定CAVPG的累积释放率,并采用不同释放模型拟合体外释药曲线,评价CAVPG的体外释药特性。结果优选的CAVPG的最佳处方工艺为AVP 2%,纳米银1%,纳米锌1%,Carbomer-980 0.5%,甘油5%,三乙醇胺适量,磷酸盐缓冲液(PBS,p H 6.86)补足至100 g,搅拌温度25℃;CAVPG中纳米银、纳米锌的释放曲线符合零级方程,AVP的释放曲线符合一级方程。结论 CAVPG处方组成合理,处方工艺简单,质量可控,具有开发应用前景。

Objective To optimiaze the preparation technology of compound Aloe vera L. polysaccharide gel（CAVPG）, and evaluate the in vitro release characteristics. Methods with the appearance of the blank gels, spreadability, viscosity, high temperature stability（place 55 ℃ water bath for 5 h）, low temperature stability（place-20 ℃ water bath for 24 h） as examining index, screening gel matrix preliminary; With the release degree of aloe polysaccharide, nano-silver, nano-zinc as examining index, investigating the release degree of aloe polysaccharide, nano-silver, nano-zinc in different substrates, determining the gel matrix; the orthogonal test was used to optimize the prescription craft, with the substrate consumption, glycerin dosage, mixing temperature for investigation factors. With the cumulative release degree of AVP, nano-silver and nano-zinc as index, stirring basket method was adopted to determine the cumulative release degree of AVP, nano-silver and nano-zinc. The curve of drug release in vitro was fitted with different release model to estimate the in vitro release characteristics of CAVPG. Results The optimum prescription process was Aloe vera L. Polysaccharide 2%, nano-silver 1%, nano-zinc 1%, carbomer-980 0.5%, glycerol 5%, a moderate amount of triethanolamine, with PBS buffer up to 100 g, mixing temperature 25 ℃; Compared with other in vitro release models, zero order equation was the fittest model to nano-silver and nano-zinc, the primary equation was the fittest model to AVP. Conclusion The gels of CAVPG prescription is reasonable, the prescription craft is simple, the quality is controllable. It has a development prospect.